Kornimate/medical-research-clean huggingface dataset:
trastuzumab deruxtecan (t-dxd) with or without pertuzumab versus taxane, trastuzumab and pertuzumab in her2-positive metastatic breast cancer (destiny-breast09)

Conditions: Breast Cancer; HER2-positive; Metastatic

Summary: the study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as t-dxd, ds-8201a), either alone or in combination with pertuzumab, in treating patients with human epidermal growth factor receptor 2 (her2)-positive breast cancer as a first line of treatment in the metastatic setting.

eligible participants will be those diagnosed with her2-positive (ihc 3+ or ish+), metastatic breast cancer, who have received no prior chemotherapy or her2-targeted therapy for advanced or metastatic breast cancer. the study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane \[docetaxel or paclitaxel\], trastuzumab and pertuzumab). this study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. this study is also looking to see how the treatment and the cancer affects patients' quality of life.

Eligibility criteria:
key inclusion criteria: * patients must be ≥18 years of age * pathologically documented breast cancer that: 1. is advanced or metastatic 2. is locally assessed and prospectively centrally confirmed as her2-positive (ihc3+ or ish+) 3. is documented by local testing as hormone receptor (hr)-positive or hr-negative disease in the metastatic setting * no prior chemotherapy or her2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. participants who have received chemotherapy or her2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if \> 6 months from treatment to metastatic diagnosis. * has protocol-defined adequate organ and bone marrow function * ecog performance status 0 or 1 key exclusion criteria: * ineligible for any of the agents on the study. * any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results * patients with spinal cord compression or clinically active central nervous system metastases. participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study. * active or prior documented interstitial lung disease (ild)/pneumonitis or suspected ild/pneumonitis that cannot be ruled out by imaging at screening * prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

Keywords: breast neoplasms; breast diseases; trastuzumab; antineoplastic agents, phytogenic; anti-drug conjugate; molecular mechanisms of pharmacological action;
peripheral modulation of muscle stiffness and spasticity

Conditions: Muscle Spasticity

Summary: this is a single-center, double-blind, randomized, placebo-controlled, sequential phase ii trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. the investigators will recruit 56 subjects, who will be randomized to receive either the intervention or normal saline injections (first injection), and then the intervention the participants did not receive first (second injection). all individuals will receive the treatment by the end of the study.

1. to test the effect of hyaluronidase injections on upper limb outcomes. the investigators will test the hypothesis that compared to placebo, human recombinant hyaluronidase injections will increase passive range of motion (rom) in the most affected joint of the upper limb (primary outcome), isometric muscle strength or force generation capacity using maximum voluntary contraction (mvc) on electromyography (emg), reduce upper limb motor impairment as measured by the fugl-meyer (fm) scale, and improve function as measured by the wolf motor function test (wmft). 2. to evaluate the effect of hyaluronidase on neural and non-neural components of muscle stiffness. the investigators will test the hypothesis that compared to placebo, intramuscular (im) hyaluronidase will modulate the passive and potentially also the active component of the stretch reflex, reduce stiffness and improve arm motor control. 3. to determine the effect of hyaluronidase on intramuscular glycosaminoglycans (gag) content. the investigators will test the hypothesis that compared to placebo, im hyaluronidase will reduce the t1rho relaxation times in the biceps and triceps muscles of the affected arm.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke 4-180 months prior * moderately-severe muscle stiffness * lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb; * willingness to have mri, complete all clinical assessments, and comply with study protocols; * ability to give informed consent and hippa certifications; and exclusion criteria: * treatment of spasticity with botulinum toxin or intrathecal baclofen within the past six months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications; * other neurologic condition that may affect motor response (e.g., parkinson's disease, amyotrophic lateral sclerosis (als), ms); * clinically significant cognitive dysfunction with score \ 10 on the patient health questionnaire-9 (phq-9); * pregnancy; * known hypersensitivity to hyaluronidase; * claustrophobia; * standard contraindications for mri * any condition that will preclude the patient from completing the protocol as determined by the pi

Keywords: muscle stiffness muscle spasticity stroke cerebral palsy hyperreflexia
red cell distribution width versus presepsin (soluble cd14) as a prognostic marker in critically-ill sepsis patients

Conditions: Sepsis

Summary: presepsin (soluble cd14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. patients with sepsis showed higher prsepsin levels compared to those with sirs. in addition the increase in prsepsin levels correlates well with sepsis severity. red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between presepsin (soluble cd14) and rdw as prognostic markers in critically-ill patients with sepsis.


Eligibility criteria:
inclusion criteria: * male or female aged 18 65 years. * appropriate clinical data to enable classification into sepsis or sirs according to third international consensus definitions for sepsis and septic shock (sepsis-3). * written informed consent by the patient or guardian exclusion criteria: * no informed consent * renal failure * liver failure * hematologic diseases * neutropenia * malignancy * chemotherapy during the previous 90 days. * patients using antibiotics at presentation

Keywords: sepsis presepsin red cell distribution width
menstrual cycle-induced pain, fatigue and anxiety in women suffered from covid-19

Conditions: Menstrual Problem; Covid19; Fatigue

Summary: the effects of covid-19 on body systems and functions are still being investigated. ace 2, which plays a key role in the entry of the covid-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. the aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from covid-19.

the effects of covid-19 on body systems and functions are still being investigated. ace 2, which plays a key role in the entry of the covid-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. it has been examined that menstruation volume decreased or cycle lengthened in one-fifth of women who had covid-19, and this condition was more intense in those who had severe covid-19. studies have shown that the possible effects of covid-19 on the female genital system often remain theoretical hypotheses. in the literature, there was no study in which menstrual dysfunctions and secondary problems caused by the state of inactivity entering our lives during pandemic were discussed in a wide spectrum of women who had covid-19. therefore the aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from covid-19.

Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 45, * pcr test result positive confirmed having covid-19 infection, * women had at least one period of menstrual cycle after covid-19 * being an internet connection, * to be able to speak and write in turkish. exclusion criteria: * to be in the premenaposual/postmenopausal period (to be in the transition period to menopause or in the period after menopause.) * having insufficient co-operation.

Keywords: menstrual problem covid19 fatigue
pet fibrin imaging of dvt and pe

Conditions: Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism

Summary: this study aims to investigate a novel positron emission tomography(pet)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (pe) and deep venous thrombosis (dvt).

venous thromboembolism (vte) is one of the most common causes of death in the united states, resulting in more than 100,000 deaths annually. current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. in this study, we will use the novel fibrin-specific probe 64cu-fbp8 (copper-64 labeled fibrin binding probe 8) for pet imaging of fresh blood clots in pe and dvt. our long-term goal is to establish a novel thrombus body scan (tbs) using 64cu-fbp8 for pet imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.

Eligibility criteria:
inclusion criteria: * 18 years of age or older with a clinically significant pulmonary embolus (pe) confirmed by a filling defect in ct angiography (cta), and * subjects must receive the radiotracer injection within 72 hours of their diagnosis. exclusion criteria: * subjects \< 18 years of age * time of expected radiotracer injection \> 72 hours from the time of a positive venous duplex ultrasound or ct- angiogram * women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-hcg) test * unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea), * weight that exceeds the pet camera table limit (300 kg) * the subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 msv (millisievert). * due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). patients with a positive serum pregnancy test will be excluded. breast feeding women will also be excluded. * a pre-existing condition or use of a medication including vasopressors and tpa (tissue plasminogen activator) that in the opinion of the investigator may place the subject at a substantially increased risk * hemodynamic instability, including requiring escalating doses of vasopressor medication. * no groups designated as "special vulnerable populations" will be studied. * no exclusions will be made based on race, sex, or ethnic origin. * 64cu-fbp8 (copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with egfr (estimated glomerular filtration rate ) \< 30 will be excluded.
aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke

Conditions: Stroke, Ischemic

Summary: background: stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world. purpose: the present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke. material and method: the present study is a randomized clinical study with a control group. participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). the study was carried out with 91 patients diagnosed with stroke. the data were collected using sociodemographic status survey, oxford happiness questionnaire, piper fatigue scale, pittsburgh sleep quality index (psqi). statistical analyses were performed using spss (ibm spss statistics 24) package program. the results were interpreted using frequency tables and descriptive statistics. foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.


Eligibility criteria:
inclusion criteria: * inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem exclusion criteria: * exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the turkish language.

Keywords: foot massage aromatherapy massage happiness sleep quality fatigue
improving social functioning in people with substance use and mental health disorders using vr

Conditions: Substance Use Disorders; Mental Disorder

Summary: ropvr, a multi-centre, pragmatic randomized controlled trial (rct) aims to evaluate a vr-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. investigators will test a vr-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. the rct aims to evaluate the effectiveness of vr training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of vr training versus treatment as usual.


Eligibility criteria:
inclusion criteria: * adults aged 18 years or older receiving in-patient sud treatment in specialized addiction treatment units in south-east norway. this may include persons serving prison sentences during in-patient treatment according to the execution of sentences act in norway * having the capability to read, understand and sign the norwegian informed consent form * willing and able to attend vr training two times a week for 5 weeks exclusion criteria: * significant visual, auditory, or balance impairment or other diseases affecting safety during vr sessions (e.g., epilepsy) * current clinically significant severe mental health disorder (e.g., acute episode of psychosis or current active suicidal plans). persons with psychotic disorders or other severe mental illness are not excluded if their condition is stable. * severe travel sickness as a proxy for simulation sickness
letermovir prophylaxis for cmv infection in haplo-hsct recipients: single-center data in china

Conditions: CMV Infection; Hematopoietic Stem Cell Transplantation

Summary: in the 30 years of fighting cmv infection, the mortality rate among hsct patients has significantly reduced. now, the focus is on improving the prognosis of hsct patients and preventing cmv infection. the emergence of letermovir has provided a new opportunity in this regard. letermovir, the only drug approved for cmv infection prevention in hsct patients, works by inhibiting the cmv dna terminase complex. phase iii studies have shown that letermovir significantly reduces cmv infection and all-cause mortality after hsct, without increasing myelosuppression or nephrotoxicity. real-world studies have further confirmed its efficacy in reducing cmv infection rates and antiviral use. letermovir's global success has not yet been fully realized in china, where it is still in its early stages of use.

letermovir achieved excellent therapeutic outcomes globally but is still developing in china. it received an implied license for clinical trials in june 2020, followed by marketing applications in november 2020. in december 2021, it was approved by the china national medical products administration (nmpa) for preventing cmv infection and disease in cmv seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (hsct). letermovir's commercial launch in china is expected in august 2022. given that over 90% of the chinese population is cmv seropositive, determining whether cmv prevention is necessary based solely on serology is insufficient. the growing use of haploidentical stem cell transplantation (haplo-sct) in china, particularly using the beijing protocol for gvhd prevention, increases cmv risk. however, limited data exists on the efficacy of cmv prophylaxis for haplo-sct patients in china. a real-life study assessing the efficacy, resistance, and tolerability of letermovir in this patient group is essential to guide cmv management strategies, particularly for high-risk cmv r+ haploidentical transplant recipients. this prospective study aims to evaluate letermovir's real-life impact on efficacy, resistance, tolerability, and cmv-related morbidity and mortality in china.

Eligibility criteria:
inclusion criteria: * haplo-sct candidate (adult) who has decided to primary transplant and is willing to participate in the study. * the haplo-sct candidate (adult) should be cmv seropositive recipients. exclusion criteria: * cmv-seronegative patient receiving a negative cmv donor graft. * patients having active cmv dnaemia at the time of letermovir initiation. * patient having signed the informed consent but not grafted. * patient recruited in a clinical study on an anti-cmv trial.

Keywords: letermovir; cytomegalovirus infection; haploidentical hsct
tirofiban for reduction of thromboembolic events in endovascular unruptured aneurysm repair

Conditions: Unruptured Intracranial Aneurysm; Flow Diverter; Stent-assisted Coiling; Thromboembolic Events

Summary: to explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative dwi sequences compared to conventional dual antiplatelet therapy.

this is a single-center, open-label, assessor-blinded randomized controlled trial. participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. the primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (dwi) within 48 hours after procedure.

Eligibility criteria:
inclusion criteria: 1. ages 18-80. 2. participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices. 3. completement of preoperative antiplatelet preparation. 4. signed informed consent. exclusion criteria: 1. abnormal platelet count (normal reference is 100-300×10\^9/l). 2. allergy to study drugs and anesthetics. 3. contradictory to mri examination. 4. known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm). 5. known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months. 6. clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis). 7. antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days; 8. participants with recurrent aneurysms who have received neurointerventional treatment. 9. inability to follow endovascular procedures due to anatomical difficulties. 10. severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (alt or ast \> twice the upper limit of normal range) insufficiency. 11. severe heart failure (nyha classes iii and iv) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope. 12. pregnant.
safety of ds-1040b in acute ischemic stroke patients treated with thrombectomy

Conditions: Acute Ischemic Stroke

Summary: the aim of this study is to find out if ds-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. four groups will receive different doses of ds-1040b by intravenous infusion for 6 hours. groups with the lowest dose will start. when it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.


Eligibility criteria:
inclusion criteria: * is an acute ischemic stroke patients with evidence of intracranial vascular occlusion * is enrolled in principle within 8 hours of symptom onset * has treatment plan that includes stent retriever * has protocol-defined scores on several scales exclusion criteria: * has treatment plan that includes fibrinolysis or fibinolysis * has identified intracranial hemorrhage or subarachnoid hemorrhage * has active bleeding like gastrointestinal hemorrhage * has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding * has severe hepatic or renal impairment * has been a participant in other clinical trial within 30 days prior to treatment * is pregnant, lactating, or planning on becoming pregnant during treatment period * has any condition or history that might, per protocol or in the opinion of the investigator, compromise: 1. safety or well-being of the participant or their offspring 2. safety of the study staff 3. analysis of results

Keywords: fibrinolysis enhancer tafia inhibitor developmental phase i